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Auditing and Validation Services for FDA Regulated Industry

Scope Of Audit (SOA) - General Audit Scope

The Auditing Group, Inc. (TAG) - Providing extensive Auditing against regulatory and quality requirements based upon your Risks and Applicability.

We take into consideration;

  1. Your Product – Safety, Purity, Quality, and Efficacy
  2. Risk to Consumers, Sponsors and Clients
  3. Agency and Regulatory Risk

TAG Provides an in-depth evaluation of cGMP minimum requirements pertaining to;

  • Finished Products and all direct and indirect involvement with the efficacy, safety, quality, validity, safety, and purity (combination Products).
  • All supporting services, i.e. Vendors, Suppliers, Contractors and Consultants
  • Development of formal Risk Assessments (Risk by Agency, to Sponsor and Consumer)

Procedures as required, based upon applicability and risk, may include inspection of procedures supporting, but not limited to (not all may be applicable);

  • Quality Assurance Procedures (applicable to 21 CFR Parts pertaining to Scope of Work (SOW))
  • Quality Assurance Manual (if applicable)
  • Site Master Plan (if applicable)
  • Site Qualification Plans (if applicable)
  • Quality Audit Procedures (Internal, External and Agency/Client Initiated)
  • Audit Reports (Agency, Sponsor and Clients/Customers (if applicable))
  • Vendor / Supplier Management Procedures (Quality Agreement reviews)
  • Quality Control Procedures
  • Good Laboratory Practice Procedures (GMP/GLP/GCP applicability Including IPC points)
  • Recall Process (Full Traceability requirement from raw materials/components to final distribution records)
  • Complaint Management
  • Change Control
  • Corrective Action and Preventive Action (CAPA)
  • Non-Conformance
  • Out-of-Specifications
  • Deviation Management
  • HACCP Quality Management Procedures and Practices (if applicable)
  • Training and Development Processes/Plans
  • Training Records (pertaining to SOW)
  • Employee Management (CV Review, Hiring and Releasing Practices)
  • Safety (Employee, Consumer and Products)
  • Facilities Management
  • Security Operations and Systems
  • Risk Management Procedures
  • Production Procedures
  • Rework and/or Reprocessing (if applicable)
  • Packaging Procedures
  • Sanitary and Housekeeping Procedures
  • Hygiene and Gowning Procedures (if applicable)
  • Pest Control Procedures
  • Water Systems Quality Procedures
  • Equipment Control, Asset Management, Maintenance and Calibration Management Procedures (Facilities, Utilities and Process Equipment)
  • Environmental Controls (Temperature, Humidity and Balancing loads)
  • Validation and Qualification Management Operations (Facilities, Process, Equipment, Computer Systems and Software, Cleaning and Analytical (if applicable))
  • Document Management, Review and Document Control, (Quality and Business Critical)
  • IT Management, Systems, Software, Network Security and Control, and 21 CFR Part 11 Compliance (if applicable)
  • Batch Management Records (Master Records; Executed Records (Drug / Combination Device)
  • Device Master Records, Device History Records and Component Engineering analysis (Device / Combination)
  • Business Continuity Procedures
  • Data Management and Record Reviews
  • Quality Management Review Meetings
  • Warehouse Management, Receiving, Sampling, Storing and Handling Procedures
  • Supply Chain Management and Traceability
  • Retains and Reserve Sample Procedures (if applicable)
  • Returns Materials
  • Stability Management (if applicable)
  • Transfer of Responsibilities Procedures
  • Regulatory Affairs
  • Record Review - Analytical, Manufacturing and QC Data

The Standard audit agenda objectives;

  • Introductions, Audit Scope and Objectives discussions
  • Facility tours (based upon applicability)
  • Procedure and quality document review (based upon applicability and audit scope)
  • Process review (Device, Drug)
  • Interviews with key relevant staff (based upon audit objective)
  • Employee CVs and training record review
  • Electronic systems (based on applicability)
  • Engineering, Maintenance and Calibrations
  • Validation and Qualification

Interviews with applicable key personnel (as required based upon Scope of Audit);

  • Quality Assurance Manager or Director (or Qualified Person(s))
  • Document Control Manager or Director
  • Quality Control Manager or Director
  • Laboratory Manager or Director, if applicable
  • Maintenance and Engineering Manager or Director, if applicable
  • IT, MIS, IS Manager or Director
  • Production Manufacturing Manager or Director, if applicable
  • Human Resources (HR) Manager or Director
  • Validation Manager or Director, if applicable


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